Angiotech Announces Encouraging Results From MS Study
Angiotech Announces Treatment Extension Results from Secondary Progressive Multiple Sclerosis Study
Angiotech Pharmaceuticals, Inc. today announced encouraging preliminary results from the treatment extension phase of its Phase I/II clinical study of paclitaxel for the treatment of secondary progressive multiple sclerosis.
In October 1999, Angiotech reported data at the American Neurological Association's Annual Meeting outlining initial six-month results from the study, which was conducted by Dr. Paul O'Connor at St. Michael's Hospital in Toronto. Twenty-nine patients were treated monthly with 25 mg/m2 or 50 mg/m2 of paclitaxel and both treatment groups demonstrated favorable trends in disability scores. In the high-dose group, patients showed a significant improvement in all tests undertaken, including functional testing, quality of life measures and changes in the amount of brain tissue scarring demonstrated by magnetic resonance imaging (MRI). Based on these results, and for compassionate reasons, the investigators and Angiotech elected to treat 22 of the patients at 50 mg/m2 for an additional six-month period.
Throughout the entire course of the study, the primary objective was met, as the drug was demonstrated to be safe and well tolerated in this patient population (no drug-related serious adverse events were reported). In addition, patients continued to show favorable trends in both clinical disability and MRI outcome measures during the extension period. Clinical disability, measured monthly using the Expanded Disability Status Scale (EDSS), showed that more than 95% of the patients (21 out of 22) remained stable or improved after twelve treatments administered over a 16-month time span. Fifteen patients demonstrated disease stabilization, six showed confirmed disease improvement and only one patient exhibited confirmed disease progression. The average EDSS score among all patients improved by 0.205 over the 16-month period.
Before and after each six-month treatment phase (at Baseline, Month 6, Month 10 and Month 16) patients were assessed by MRI. Preliminary results indicate that patients treated at 50 mg/m2 for the entire study showed favorable trends in gadolinium enhancing lesions, burden of disease, validated lesion number, black hole number and black hole volume. The above MRI measures will be further evaluated in the Company's recently initiated 189-patient, Phase II clinical study, which utilizes MRI parameters as the primary outcome.